510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872591Substantially Equivalent

Hard Contact Lens Remover. Item #289

FGX International Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872591 is the FDA 510(k) clearance record for HARD CONTACT LENS REMOVER. ITEM #289, a class I device, cleared for Magnivision, Inc. on under FDA product code KYE (Inserter/Remover Contact Lens). FDA records list 8 510(k) clearances for FGX International Inc., from to . As of , FDA records show no recalls naming K872591.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KYE Inserter/Remover Contact Lens
Regulation
21 CFR 886.5420
Device class
Class I
Review panel
Ophthalmic
Applicant
Magnivision, Inc. P.O. Box 817, Miami FL
Third party review
No

Clearances, product code KYE

Trailing 12 months

FDA records hold no clearances under product code KYE in the trailing twelve months.

FDA records show no clearances under product code KYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260